Senior Quality Specialist

**Nashville, Tennessee (On-site)About the *In this role, you'll play a key part in ensuring the quality, safety, and compliance of our manufacturing operations. You will support quality control, manage the Quality Management System (QMS), and take ownership of document control processes.Key *Oversee and maintain the Quality Management System (QMS) in accordance with ISO 13485 and FDA 21 CFR Part 820Support manufacturing operations through quality inspections, audits, and data analysisManage Document Control processes, including SOPs, forms, and records lifecycleLead and support CAPA, NCR, and complaint investigationsCollaborate cross-functionally with Engineering, Production, and Regulatory teams to ensure compliance and readinessAssist in internal and external audits (FDA, ISO, customer)Participate in supplier quality assurance, including evaluations and performance monitoringSupport ongoing continuous improvement initiatives across the quality systemBachelor's degree in Engineering, Life Sciences, or related field4+ years of experience in Quality Assurance within the medical device industryStrong knowledge of ISO 13485, FDA QSR, and QMS best practicesHands-on experience with document control systems and quality records managementFamiliarity with quality tools (CAPA, Root Cause Analysis, Risk Management)Excellent communication, organization, and problem-solving skills***Experience in a manufacturing settingProficiency in electronic QMS/document control systems (e.g., MasterControl, Greenlight Guru)Auditor certification (CQA, ISO 13485 Lead Auditor) a plus

Created: 2025-05-31